Gimbo Medical Technology Shenzhen Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 3 device types, 11 products catalogued, 7 clearances.
Gimbo Medical Technology Shenzhen Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Media, Reproductive, Needle, Assisted Reproduction and 1 other device type. 11 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
3device types registered with the FDA
11products catalogued under its own name
7510(k) clearances
Registration
| Registered name | GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3030681110 |
| FEI number | 3030681110 |
| DUNS | 722458269 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 金宝医学科技（深圳）有限公司 |
|---|---|
| Unified social credit code | 91440300MA5GD6ND04 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Provinc |
| Postal code | 518107 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Labware, Assisted Reproduction | Class 2 | G-Vitri™ Vitrification Straw | 2024 | 10 |
| Media, Reproductive | Class 2 | G-vitri Vitrification media; G-vitri Warming media, Oocyte Flushing & Retrieval Medium; Gamete Buffer, Giftlife® Single-Step Medium Plus, Sperm Freezing Medium, Giftlife™ Cleavage Medium, Giftlife™ Blastocyst Medium and 2 more | 2024 | 4 |
| Needle, Assisted Reproduction | Class 2 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | 2026 | 3 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| G-Vitri™ Vitrification Straw | MQK | 15 |
| G-Vitri™ Vitrification media | MQL | 7 |
| Gamete Buffer | MQL | 4 |
| Oocyte Flushing & Retrieval Medium | MQL | 4 |
| G-Vitri™ Warming media | MQL | 4 |
| Giftlife™ Fertilization Medium | MQL | 3 |
| Giftlife™ Single Step Medium | MQL | 3 |
| Giftlife™ Blastocyst Medium | MQL | 3 |
| Giftlife™ Cleavage Medium | MQL | 3 |
| Sperm Freezing Medium | MQL | 2 |
| Single Step Medium Plus | MQL | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253121 | 2026-06-15 | MQE | Traditional | This company |
| K242043 | 2025-01-08 | MQL | Traditional | This company |
| K242968 | 2024-11-22 | MQL | Traditional | This company |
| K240002 | 2024-06-14 | MQK | Traditional | This company |
| K240149 | 2024-06-13 | MQL | Traditional | This company |
| K234023 | 2024-05-10 | MQL | Traditional | This company |
| K232942 | 2024-01-30 | MQL | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.